A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension

This study has been completed.

Sponsor:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00894322

First Posted: May 7, 2009

Last Update Posted: September 18, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Healthy participants were enrolled in Cohort 1 while participants with type 2 diabetes mellitus were enrolled in Cohort 2.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Enrolled participants in Cohort 1 were treated on Day 1 only. Enrolled participants who were in Cohort 2 were randomized to one of 2 treatment arms (exenatide or placebo) and were treated for 12 weeks.

Reporting Groups

Description

Cohort 1 Exenatide 10 mg

A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.

Cohort 2 Exenatide 2 mg

On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.

Cohort 2 Placebo

On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Intent to treat (ITT) population. All randomized participants who received at least 1 dose of study medication were included in the ITT population. Totals presented are for only Cohort 2 (35 participants), not for both Cohort 1 and 2.

Reporting Groups

Description

Cohort 1 Exenatide 10 mg

A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.

Cohort 2 Exenatide 2 mg

On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.

Cohort 2 Placebo

On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).

Total

Total of all reporting groups

Baseline Measures

Cohort 1 Exenatide 10 mg

Cohort 2 Exenatide 2 mg

Cohort 2 Placebo

Total

Overall Participants Analyzed [Units: Participants]

30

23

12

65

Age [Units: Years]Mean (Standard Deviation)

41.2 (14.4)

52.7 (11.6)

52.0 (9.3)

52.4 (10.7)

Gender [Units: Participants]

Female

12

9

2

23

Male

18

14

10

42

Race/Ethnicity, Customized [Units: Participants]

Caucasian

23

19

11

53

Black

3

1

0

4

Asian

0

0

1

1

Native American

1

1

0

2

Hispanic

3

2

0

5

Region of Enrollment [Units: Participants]

United States

30

23

12

65

Body Weight [Units: Kilograms]Mean (Standard Deviation)

85.9 (15.5)

104.9 (23.2)

104.4 (20.3)

104.7 (22.0)

Body Mass Index (BMI) [1] [Units: Kg/m^2]Mean (Standard Deviation)

28.5 (3.5)

35.3 (6.7)

34.9 (4.9)

35.1 (6.1)

[1]

BMI was measured in kilograms (kg) of body weight per meter (m) of height, squared.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Injection Site TEAEs, Serious Adverse Events (SAEs), Deaths, and Withdrawals Due to AEs in Cohort 1 and Cohort 2 in Intent to Treat (ITT) Population [ Time Frame: Day 1 to Week12 ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.